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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7106-24
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Manufacturer Narrative
Operator of device: patient/consumer. No product has been returned to date. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available.
 
Event Description
It was reported that the tubing had kinks. No patient injury was reported.
 
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Brand NameCADD EXTENSION SET WITH MICROBORE TUBING
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14946590
MDR Text Key303540618
Report Number3012307300-2022-13049
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public10610586023279
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Device Lot Number3840936
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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